TriangleNCT03000452 · OUTCOME
Apparent Volume of Distribution (Vz/F) of Durvalumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Liters
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pharmacokinetic samples were drawn on Cycle 1 on Day 2 (C1D2) pre-dose, at the end of the infusion, on Day 8 at 144 hour post dose, on Day 15 at 312 hours post dose and on Day 22 at 480 hours post C1D2 infusion.
What was measured
Apparent volume of distribution, calculated as \[(CL/F)/λz\].
Analysis population: The pharmacokinetic population included participants who received at least 1 dose of study medication and had evaluable plasma PK durvalumab profiles.
Groups in this outcome
Daratumumab and Durvalumab
Participants received intravenous daratumumab at 16 mg/kg on the same dosing schedule (weekly, every 2 weeks, or every 4 weeks of each 28-day treatment cycle) on their last prior therapy containing daratumumab regimen. The dosing schedule for daratumumab could be adjusted during the course of the study, provided the participant had a response of stable disease or better. Participants also received IV durvalumab at 1500 mg on Day 2 of Cycle 1 and then on Day 1 of Cycles ≥ 2 of each 28-day treatment cycle. Participants could continue on study treatment until progressive disease or unacceptable toxicity.
| Group | Source count |
|---|---|
| Daratumumab and Durvalumab | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Daratumumab and Durvalumab | 5.48 | 25.1 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 25.1
- value
- 5.48
- denoms
- counts
- group Id
- OG000
- value
- 10
- units
- Participants
- description
- Apparent volume of distribution, calculated as \[(CL/F)/λz\].
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received intravenous daratumumab at 16 mg/kg on the same dosing schedule (weekly, every 2 weeks, or every 4 weeks of each 28-day treatment cycle) on their last prior therapy containing daratumumab regimen. The dosing schedule for daratumumab could be adjusted during the course of the study, provided the participant had a response of stable disease or better. Participants also received IV durvalumab at 1500 mg on Day 2 of Cycle 1 and then on Day 1 of Cycles ≥ 2 of each 28-day treatment cycle. Participants could continue on study treatment until progressive disease or unacceptable toxicity.
- id
- OG000
- title
- Daratumumab and Durvalumab
- param Type
- GEOMETRIC_MEAN
- population Description
- The pharmacokinetic population included participants who received at least 1 dose of study medication and had evaluable plasma PK durvalumab profiles.
- reporting Status
- POSTED
- time Frame
- Pharmacokinetic samples were drawn on Cycle 1 on Day 2 (C1D2) pre-dose, at the end of the infusion, on Day 8 at 144 hour post dose, on Day 15 at 312 hours post dose and on Day 22 at 480 hours post C1D2 infusion.
- title
- Apparent Volume of Distribution (Vz/F) of Durvalumab
- type
- SECONDARY
- unit Of Measure
- Liters
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice